APL-2 ( DrugBank: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 6 |
| 61 | 自己免疫性溶血性貧血 | 4 |
| 62 | 発作性夜間ヘモグロビン尿症 | 21 |
| 66 | IgA腎症 | 1 |
| 222 | 一次性ネフローゼ症候群 | 14 |
2. 筋萎縮性側索硬化症
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003797-10-NL (EUCTR) | 23/07/2021 | 09/11/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 2 | EUCTR2019-003797-10-CZ (EUCTR) | 13/05/2021 | 27/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 3 | EUCTR2019-003797-10-IE (EUCTR) | 06/04/2021 | 03/09/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Netherlands;Germany;Japan | ||
| 4 | EUCTR2019-003797-10-DE (EUCTR) | 18/02/2021 | 12/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 5 | EUCTR2019-003797-10-IT (EUCTR) | 03/02/2021 | 28/07/2021 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplam Product Code: [APL-2] Other descriptive name: N/A | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 6 | NCT04579666 (ClinicalTrials.gov) | September 30, 2020 | 22/9/2020 | MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Pegcetacoplan (APL-2);Other: Placebo | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 249 | Phase 2 | United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-003160-27-HU (EUCTR) | 19/04/2022 | 23/02/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 2 | EUCTR2021-003160-27-ES (EUCTR) | 04/04/2022 | 05/04/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 3 | EUCTR2017-003363-35-IT (EUCTR) | 05/07/2018 | 04/11/2020 | Clinical study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). - Treatment of wAIHA with APL-2 | Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) MedDRA version: 20.0;Level: LLT;Classification code 10002045;Term: Anaemia haemolytic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 | APELLIS PHARMACEUTCIALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United States;Italy | ||
| 4 | NCT03226678 (ClinicalTrials.gov) | August 31, 2017 | 7/7/2017 | Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | Warm Autoimmune Hemolytic Anemia;Cold Agglutinin Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 292 / 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2031220046 | 28/04/2022 | 28/04/2022 | Pegcetacoplan Long-term Safety and Efficacy Extension Study | AN OPEN-LABEL, NONRANDOMIZED, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - APL2-307 | Paroxysmal Nocturnal Hemoglobinuria (PNH) | A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice a week, 3 times a week or every 3 days | Machaidze Zurab | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 10 | Phase 3 | the United States;South Korea;Australia;Malaysia;Hong Kong;Philippines;Singapore;Thailand;Peru;Colombia;Mexico;Canada;Bulgaria;Serbia;Belgium;France;Germany;Italy;the Netherlands;Russia;Spain;the United Kingdom;Japan |
| 2 | JPRN-jRCT2031210645 | 04/03/2022 | 04/03/2022 | A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | Paroxysmal Nocturnal Hemoglobinuria (PNH) | A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice weekly (or change to a dose of 1080 mg every 3 days as necessary). | Machaidze Zurab | NULL | Complete | >= 18age old | Not applicable | Both | 8 | Phase 3 | the U.S.;Korea;Australia;Canada;Belgium;France;Germany;Russia;Spain;the United Kingdom;Japan |
| 3 | EUCTR2019-001106-23-FR (EUCTR) | 04/02/2020 | 15/10/2019 | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Phase 3 | United States;Serbia;Hong Kong;Thailand;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2019-001106-23-ES (EUCTR) | 22/01/2020 | 14/01/2020 | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 5 | EUCTR2019-001106-23-GB (EUCTR) | 19/12/2019 | 30/09/2019 | An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: pegcetacoplan Other descriptive name: Pegcetacoplan (APL-2) | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Japan;Korea, Republic of | ||
| 6 | NCT04085601 (ClinicalTrials.gov) | August 27, 2019 | 9/9/2019 | A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH | A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 53 | Phase 3 | Colombia;Hong Kong;Malaysia;Mexico;Peru;Philippines;Poland;Serbia;Singapore;Thailand |
| 7 | EUCTR2018-004220-11-PL (EUCTR) | 23/07/2019 | 13/05/2019 | A Research Study to Gather Scientific Information About the Efficacy and Safety of the Investigational Drug APL-2 In Treating Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated with Anemia, In a Randomly Assigned Comparison with the Current Standard of Care Treatment Approved for PNH | A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PRINCE | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Serbia;Philippines;Hungary;Hong Kong;Mexico;Argentina;Thailand;Malaysia;Brazil;Poland;Peru;Colombia | ||
| 8 | EUCTR2017-004268-36-NL (EUCTR) | 23/05/2019 | 09/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 9 | EUCTR2017-004268-36-IT (EUCTR) | 04/03/2019 | 26/09/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 10 | EUCTR2017-004268-36-GB (EUCTR) | 08/01/2019 | 21/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug Pegcetacoplan In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 11 | EUCTR2017-004268-36-BE (EUCTR) | 25/10/2018 | 23/07/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 12 | EUCTR2017-004268-36-FR (EUCTR) | 05/10/2018 | 20/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 13 | EUCTR2017-004268-36-DE (EUCTR) | 01/10/2018 | 14/06/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 14 | EUCTR2017-004268-36-ES (EUCTR) | 19/09/2018 | 07/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 15 | NCT03593200 (ClinicalTrials.gov) | August 16, 2018 | 28/6/2018 | A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With PNH | Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH). | PNH | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 4 | Phase 2 | Bulgaria;Serbia;Greece;Poland;Romania |
| 16 | EUCTR2017-005140-16-BG (EUCTR) | 18/07/2018 | 26/03/2018 | Phase IIa study of APL-2 in patients with PNH | A Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: APL-2 INN or Proposed INN: Not yet assigned | Apellis Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Serbia;Greece;Poland;Romania;Bulgaria | ||
| 17 | NCT03500549 (ClinicalTrials.gov) | June 14, 2018 | 10/4/2018 | Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria | Drug: APL-2;Drug: Soliris | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom |
| 18 | EUCTR2017-005140-16-GR (EUCTR) | 04/05/2018 | 02/04/2018 | Phase IIa study of APL-2 in patients with PNH | A Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: APL-2 INN or Proposed INN: Not yet assigned | Apellis Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Greece;Poland;Romania;Bulgaria | ||
| 19 | NCT02588833 (ClinicalTrials.gov) | November 2015 | 27/10/2015 | Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. APL-2 in PNH Subjects | A Phase Ib, Open Label, Multiple Ascending Dose, Pilot Study to Assess the Safety, Preliminary Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | Hong Kong;Malaysia;New Zealand;Thailand |
| 20 | NCT02264639 (ClinicalTrials.gov) | February 23, 2015 | 8/10/2014 | A Phase I Study to Assess the Safety APL-2 as an Add-On to Standard of Care in Subjects With PNH | An Open Label, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL-2 as an Add-On to Standard of Care in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH). | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 9 | Phase 1 | United States |
| 21 | EUCTR2019-001106-23-DE (EUCTR) | 30/09/2019 | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). | Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Aspaveli Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: pegcetacoplan Other descriptive name: Pegcetacoplan (APL-2) | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Serbia;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Germany;Japan;Korea, Republic of |
66. IgA腎症
臨床試験数 : 275 / 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03453619 (ClinicalTrials.gov) | January 22, 2018 | 27/2/2018 | Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies | A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease) | IgA Nephropathy;Lupus Nephritis;Membranous Nephropathy;C3 Glomerulonephritis;Dense Deposit Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States |
222. 一次性ネフローゼ症候群
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-003767-25-DE (EUCTR) | 08/03/2022 | 04/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-003767-25-ES (EUCTR) | 25/02/2022 | 25/02/2022 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2020-003767-25-NL (EUCTR) | 16/02/2022 | 13/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Germany;Netherlands;Japan;Korea, Republic of | ||
| 4 | EUCTR2020-003767-25-PL (EUCTR) | 08/02/2022 | 09/11/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Australia;Peru;Germany;Netherlands;Japan;Korea, Republic of | ||
| 5 | EUCTR2020-002637-15-FR (EUCTR) | 09/06/2021 | 02/02/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy | ||
| 6 | EUCTR2020-002637-15-IT (EUCTR) | 09/04/2021 | 04/06/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: [APL-2] INN or Proposed INN: Pegcetacoplan Trade Name: Prevenar 13 suspension for injection Product Name: Prevenar 13 suspension for injection Product Code: [na] INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg Trade Name: Pneumococcal polysaccharide vaccine Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial Product Code: [na] INN or Proposed INN: Pneumococcal Polysaccharide Vaccine Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States | ||
| 7 | EUCTR2020-002637-15-AT (EUCTR) | 01/04/2021 | 23/12/2020 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Argentina;Spain;Brazil;Australia;Austria;Netherlands;United Kingdom;Italy;Switzerland | ||
| 8 | EUCTR2020-002637-15-NL (EUCTR) | 29/03/2021 | 04/01/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Italy;Switzerland;United Kingdom | ||
| 9 | EUCTR2020-002637-15-GB (EUCTR) | 22/12/2020 | 23/10/2020 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom | ||
| 10 | NCT03453619 (ClinicalTrials.gov) | January 22, 2018 | 27/2/2018 | Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies | A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease) | IgA Nephropathy;Lupus Nephritis;Membranous Nephropathy;C3 Glomerulonephritis;Dense Deposit Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 11 | EUCTR2020-003767-25-CZ (EUCTR) | 15/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of | |||
| 12 | EUCTR2020-003767-25-AT (EUCTR) | 20/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of | |||
| 13 | EUCTR2020-003767-25-BE (EUCTR) | 19/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of | |||
| 14 | EUCTR2020-003767-25-FR (EUCTR) | 29/10/2021 | A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of |